-
Je něco špatně v tomto záznamu ?
Patient-reported outcomes from the MIRASOL trial evaluating mirvetuximab soravtansine versus chemotherapy in patients with folate receptor α-positive, platinum-resistant ovarian cancer: a randomised, open-label, phase 3 trial
T. Van Gorp, KN. Moore, GE. Konecny, A. Leary, Y. García-García, S. Banerjee, D. Lorusso, JY. Lee, JW. Moroney, G. Caruso, D. Klasa-Mazurkiewicz, J. Tromp, LP. Martin, S. Breuer, CA. Leath, D. Cibula, SJ. Weroha, P. Estévez-García, DM. O'Malley,...
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, klinické zkoušky, fáze III, randomizované kontrolované studie, multicentrická studie, srovnávací studie
NLK
ProQuest Central
od 2000-09-01 do Před 2 měsíci
Nursing & Allied Health Database (ProQuest)
od 2000-09-01 do Před 2 měsíci
Health & Medicine (ProQuest)
od 2000-09-01 do Před 2 měsíci
Public Health Database (ProQuest)
od 2000-09-01 do Před 2 měsíci
- MeSH
- chemorezistence * účinky léků MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- epiteliální ovariální karcinom * farmakoterapie mortalita patologie MeSH
- folátový receptor 1 * metabolismus antagonisté a inhibitory MeSH
- hodnocení výsledků péče pacientem * MeSH
- humanizované monoklonální protilátky * terapeutické užití škodlivé účinky MeSH
- imunokonjugáty * terapeutické užití škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- maytansin * analogy a deriváty terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- nádory vaječníků * farmakoterapie patologie mortalita metabolismus MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití škodlivé účinky MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class antibody-drug conjugate targeting folate receptor α (FRα), approved by the US Food and Drug Administration for the treatment of platinum-resistant ovarian cancer in the USA. Here, we report patient-reported outcomes for participants treated with MIRV compared with investigator's choice of chemotherapy from the phase 3 MIRASOL trial, which met its primary endpoint of progression-free survival and key secondary endpoints of objective response rate and overall survival. METHODS: The MIRASOL trial was a confirmatory, phase 3, randomised, controlled, open-label trial, building on the phase 2 SORAYA trial which had previously demonstrated the safety and efficacy of MIRV in platinum-resistant ovarian cancer. Patients 18 years or older with a confirmed platinum-resistant, recurrent high-grade serous epithelial ovarian cancer diagnosis were recruited from 253 sites including hospitals, academic centres, and community centres in 21 countries. Patients must have received one to three previous systemic anticancer therapies, and have high FRα tumour expression (≥75% tumour cells with an immunohistochemistry score of ≥2+ membrane staining using the PS2+ scoring method), one or more lesions with measurable disease, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (1:1) to MIRV or investigator's choice of chemotherapy, stratified by number of previous therapy lines and the type of investigator's choice of chemotherapy. Therapies were administered in an open-label manner; MIRV was administered intravenously at 6 mg/kg of adjusted ideal bodyweight every 3 weeks. The primary endpoint was progression-free survival. Key secondary endpoints were objective response rate, overall survival, and a 15·0-point or greater improvement at week 8 or 9 in abdominal and gastrointestinal symptoms using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (EORTC QLQ-OV28) in the intention-to-treat population. The MIRASOL trial was registered at ClinicalTrials.gov (NCT04209855), the Gynecologic Oncology Group (GOG 3045), and the European Network of Gynaecological Oncological Trial Groups (ENGOT-ov55), and is complete. FINDINGS: Between Feb 3, 2020, and Aug 3, 2022, 453 patients were enrolled and randomly assigned to treatment (227 to the MIRV group and 226 to the investigator's choice of chemotherapy group). All patients were female; 301 (66%) participants were White, 53 (12%) were Asian, 13 (3%) were Black, and 86 (19%) were of another race or not reported; 27 (6%) were Hispanic or Latino. The median follow-up for the study, determined by the reverse Kaplan-Meier method, was 13·1 months (95% CI 12·1-14). QLQ-OV28 completion rates were 86% (365 of 425) at baseline and 81% (282 of 349) at week 8 or 9. 34 (21·0%; 95% CI 15·0-28·1) of 162 patients treated with MIRV reported improvement in QLQ-OV28 abdominal and gastrointestinal scores, compared with 23 (15·3%; 10·0-22·1) of 150 patients treated with the investigator's choice of chemotherapy. These differences were not statistically significant (odds ratio 1·5 [95% CI 0·8-2·6]; p=0·26). INTERPRETATION: MIRV did not seem to impair or improve patient quality of life compared with investigator's choice of chemotherapy. The similar quality-of-life outcomes in the two treatment groups, combined with the previously reported higher efficacy of MIRV compared with single-agent chemotherapy, support MIRV as new treatment option for FRα-positive platinum-resistant ovarian cancer. FUNDING: AbbVie.
Arbeitsgemeinschaft Gynäkologische Onkologie study group Wiesbaden Germany
Belgium and Luxembourg Gynaecological Oncology Group Leuven Belgium
Central and Eastern European Gynecologic Oncology Group Prague Czech Republic
CIBER de CANCER Institute of Health Carlos 3 Madrid Spain
Department of Gynecologic Oncology OU Health Stephenson Cancer Center Oklahoma City OK USA
Department of Gynecology European Institute of Oncology IRCCS Milan Italy
Department of Medical Oncology Amsterdam University Medical Center Amsterdam The Netherlands
Department of Medical Oncology Barts Health NHS Trust London UK
Department of Medical Oncology Centre Léon Bérard Lyon France
Department of Medical Oncology Gustave Roussy Villejuif France
Department of Medical Oncology University College London Hospital London UK
Department of Obstetrics and Gynecology The University of Chicago Chicago IL USA
Department of Oncology Mayo Clinic Rochester MN USA
Dutch Gynaecological Oncology Group Amsterdam The Netherlands
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
General University Hospital Prague Prague Czech Republic
Groupe d'Investigateurs National des Etudes des Cancers Ovariens et du Sein Paris France
Grupo Español de Investigación en Cáncer Ginecológico Madrid Spain
Gynecologic Oncology Group Partners Philadelphia PA USA
Helmsley Cancer Center Shaare Zedek Medical Center Jerusalem Israel
Humanitas San Pio 10 Milan Italy
Jerusalem Hospital Hamburg Germany
Kore University of Enna Enna Italy
Leuven Cancer Institute University Hospitals Leuven and KU Leuven Leuven Belgium
Mario Negri Gynecologic Oncology group Milan Italy
Medical Oncology Department Hospital Universitario Virgen del Rocío Seville Spain
Medical Oncology Institut de Cancérologie de l'Ouest Centre René Gauducheau Saint Herblain France
Medical Oncology Unit Azienda Ospedaliera Cannizzaro Catania Italy
Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies Group Seoul South Korea
National Cancer Research Institute London UK
O'Neal Comprehensive Cancer Center The University of Alabama at Birmingham Birmingham AL USA
Polish Gynecologic Oncology Group Warsaw Poland
The James Comprehensive Cancer Center The Ohio State University Columbus OH USA
UPMC Hillman Cancer Center Pittsburgh PA USA
Yonsei Cancer Center and Severance Hospital Yonsei University College of Medicine Seoul South Korea
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25016218
- 003
- CZ-PrNML
- 005
- 20250731091619.0
- 007
- ta
- 008
- 250708s2025 enk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1016/S1470-2045(25)00021-X $2 doi
- 035 __
- $a (PubMed)40179908
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a enk
- 100 1_
- $a Van Gorp, Toon $u Leuven Cancer Institute, University Hospitals Leuven and KU Leuven, Leuven, Belgium; Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven, Belgium
- 245 10
- $a Patient-reported outcomes from the MIRASOL trial evaluating mirvetuximab soravtansine versus chemotherapy in patients with folate receptor α-positive, platinum-resistant ovarian cancer: a randomised, open-label, phase 3 trial / $c T. Van Gorp, KN. Moore, GE. Konecny, A. Leary, Y. García-García, S. Banerjee, D. Lorusso, JY. Lee, JW. Moroney, G. Caruso, D. Klasa-Mazurkiewicz, J. Tromp, LP. Martin, S. Breuer, CA. Leath, D. Cibula, SJ. Weroha, P. Estévez-García, DM. O'Malley, RE. Miller, L. Coffman, G. Scandurra, D. Berton, L. Li, E. Zagadailov, EJ. Diver, O. Trédan, F. Hilpert
- 520 9_
- $a BACKGROUND: Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class antibody-drug conjugate targeting folate receptor α (FRα), approved by the US Food and Drug Administration for the treatment of platinum-resistant ovarian cancer in the USA. Here, we report patient-reported outcomes for participants treated with MIRV compared with investigator's choice of chemotherapy from the phase 3 MIRASOL trial, which met its primary endpoint of progression-free survival and key secondary endpoints of objective response rate and overall survival. METHODS: The MIRASOL trial was a confirmatory, phase 3, randomised, controlled, open-label trial, building on the phase 2 SORAYA trial which had previously demonstrated the safety and efficacy of MIRV in platinum-resistant ovarian cancer. Patients 18 years or older with a confirmed platinum-resistant, recurrent high-grade serous epithelial ovarian cancer diagnosis were recruited from 253 sites including hospitals, academic centres, and community centres in 21 countries. Patients must have received one to three previous systemic anticancer therapies, and have high FRα tumour expression (≥75% tumour cells with an immunohistochemistry score of ≥2+ membrane staining using the PS2+ scoring method), one or more lesions with measurable disease, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (1:1) to MIRV or investigator's choice of chemotherapy, stratified by number of previous therapy lines and the type of investigator's choice of chemotherapy. Therapies were administered in an open-label manner; MIRV was administered intravenously at 6 mg/kg of adjusted ideal bodyweight every 3 weeks. The primary endpoint was progression-free survival. Key secondary endpoints were objective response rate, overall survival, and a 15·0-point or greater improvement at week 8 or 9 in abdominal and gastrointestinal symptoms using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (EORTC QLQ-OV28) in the intention-to-treat population. The MIRASOL trial was registered at ClinicalTrials.gov (NCT04209855), the Gynecologic Oncology Group (GOG 3045), and the European Network of Gynaecological Oncological Trial Groups (ENGOT-ov55), and is complete. FINDINGS: Between Feb 3, 2020, and Aug 3, 2022, 453 patients were enrolled and randomly assigned to treatment (227 to the MIRV group and 226 to the investigator's choice of chemotherapy group). All patients were female; 301 (66%) participants were White, 53 (12%) were Asian, 13 (3%) were Black, and 86 (19%) were of another race or not reported; 27 (6%) were Hispanic or Latino. The median follow-up for the study, determined by the reverse Kaplan-Meier method, was 13·1 months (95% CI 12·1-14). QLQ-OV28 completion rates were 86% (365 of 425) at baseline and 81% (282 of 349) at week 8 or 9. 34 (21·0%; 95% CI 15·0-28·1) of 162 patients treated with MIRV reported improvement in QLQ-OV28 abdominal and gastrointestinal scores, compared with 23 (15·3%; 10·0-22·1) of 150 patients treated with the investigator's choice of chemotherapy. These differences were not statistically significant (odds ratio 1·5 [95% CI 0·8-2·6]; p=0·26). INTERPRETATION: MIRV did not seem to impair or improve patient quality of life compared with investigator's choice of chemotherapy. The similar quality-of-life outcomes in the two treatment groups, combined with the previously reported higher efficacy of MIRV compared with single-agent chemotherapy, support MIRV as new treatment option for FRα-positive platinum-resistant ovarian cancer. FUNDING: AbbVie.
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé středního věku $7 D008875
- 650 12
- $a folátový receptor 1 $x metabolismus $x antagonisté a inhibitory $7 D058975
- 650 12
- $a chemorezistence $x účinky léků $7 D019008
- 650 12
- $a nádory vaječníků $x farmakoterapie $x patologie $x mortalita $x metabolismus $7 D010051
- 650 12
- $a humanizované monoklonální protilátky $x terapeutické užití $x škodlivé účinky $7 D061067
- 650 _2
- $a senioři $7 D000368
- 650 12
- $a maytansin $x analogy a deriváty $x terapeutické užití $x škodlivé účinky $x aplikace a dávkování $7 D008453
- 650 12
- $a imunokonjugáty $x terapeutické užití $x škodlivé účinky $7 D018796
- 650 12
- $a hodnocení výsledků péče pacientem $7 D000071066
- 650 _2
- $a dospělí $7 D000328
- 650 12
- $a epiteliální ovariální karcinom $x farmakoterapie $x mortalita $x patologie $7 D000077216
- 650 _2
- $a doba přežití bez progrese choroby $7 D000077982
- 650 12
- $a protokoly protinádorové kombinované chemoterapie $x terapeutické užití $x škodlivé účinky $7 D000971
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a klinické zkoušky, fáze III $7 D017428
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a srovnávací studie $7 D003160
- 700 1_
- $a Moore, Kathleen N $u Department of Gynecologic Oncology, OU Health Stephenson Cancer Center, Oklahoma City, OK, USA; Gynecologic Oncology Group Partners (GOG-P), Philadelphia, PA, USA
- 700 1_
- $a Konecny, Gottfried E $u Gynecologic Oncology Group Partners (GOG-P), Philadelphia, PA, USA; UCLA Health Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA
- 700 1_
- $a Leary, Alexandra $u Department of Medical Oncology, Gustave Roussy, Villejuif, France; Groupe d'Investigateurs National des Etudes des Cancers Ovariens et du Sein (GINECO), Paris, France
- 700 1_
- $a García-García, Yolanda $u Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Barcelona, Sabadell, Spain; Grupo Español de Investigación en Cáncer Ginecológico (GEICO), Madrid Spain
- 700 1_
- $a Banerjee, Susana $u Gynaecology Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK; National Cancer Research Institute (NCRI), London, UK
- 700 1_
- $a Lorusso, Domenica $u Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; Humanitas San Pio X, Milan, Italy; Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) Group, Seoul, South Korea
- 700 1_
- $a Lee, Jung-Yun $u Yonsei Cancer Center and Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
- 700 1_
- $a Moroney, John W $u Gynecologic Oncology Group Partners (GOG-P), Philadelphia, PA, USA; Department of Obstetrics and Gynecology, The University of Chicago, Chicago, IL, USA
- 700 1_
- $a Caruso, Giuseppe $u Department of Gynecology, European Institute of Oncology (IEO) IRCCS, Milan, Italy; Mario Negri Gynecologic Oncology group (MaNGO), Milan, Italy
- 700 1_
- $a Klasa-Mazurkiewicz, Dagmara $u Division of Gynecology and Obstetrics, Department of Gynecology, Obstetrics and Neonatology, Medical University of Gdańsk, Gdańsk, Poland; Polish Gynecologic Oncology Group (PGOG), Warsaw, Poland
- 700 1_
- $a Tromp, Jacqueline $u Department of Medical Oncology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Dutch Gynaecological Oncology Group (DGOG), Amsterdam, The Netherlands
- 700 1_
- $a Martin, Lainie P $u Gynecologic Oncology Group Partners (GOG-P), Philadelphia, PA, USA; Division of Hematology/Oncology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA
- 700 1_
- $a Breuer, Shani $u Helmsley Cancer Center, Shaare Zedek Medical Center, Jerusalem, Israel
- 700 1_
- $a Leath, Charles A $u Gynecologic Oncology Group Partners (GOG-P), Philadelphia, PA, USA; O'Neal Comprehensive Cancer Center, The University of Alabama at Birmingham, Birmingham, AL, USA
- 700 1_
- $a Cibula, David $u Department of Gynaecology, Obstetrics and Neonatology, First Faculty of Medicine, Charles University, Czech Republic; General University Hospital in Prague, Prague, Czech Republic; Central and Eastern European Gynecologic Oncology Group (CEEGOG), Prague, Czech Republic
- 700 1_
- $a Weroha, S John $u Gynecologic Oncology Group Partners (GOG-P), Philadelphia, PA, USA; Department of Oncology, Mayo Clinic, Rochester, MN, USA
- 700 1_
- $a Estévez-García, Purificación $u Grupo Español de Investigación en Cáncer Ginecológico (GEICO), Madrid Spain; Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Consejo Superior de Investigaciones Científicas, Seville, Spain; Medical Oncology Department, Hospital Universitario Virgen del Rocío, Seville, Spain; CIBER de CANCER, Institute of Health Carlos III, Madrid, Spain
- 700 1_
- $a O'Malley, David M $u Gynecologic Oncology Group Partners (GOG-P), Philadelphia, PA, USA; The James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA
- 700 1_
- $a Miller, Rowan E $u National Cancer Research Institute (NCRI), London, UK; Department of Medical Oncology, Barts Health NHS Trust, London, UK; Department of Medical Oncology, University College London Hospital, London, UK
- 700 1_
- $a Coffman, Lan $u Gynecologic Oncology Group Partners (GOG-P), Philadelphia, PA, USA; UPMC Hillman Cancer Center, Pittsburgh, PA, USA
- 700 1_
- $a Scandurra, Giuseppa $u Gynecologic Oncology Group Partners (GOG-P), Philadelphia, PA, USA; Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) Group, Seoul, South Korea; Medical Oncology Unit, Azienda Ospedaliera Cannizzaro, Catania, Italy; Kore University of Enna, Enna, Italy
- 700 1_
- $a Berton, Dominique $u Groupe d'Investigateurs National des Etudes des Cancers Ovariens et du Sein (GINECO), Paris, France; Medical Oncology, Institut de Cancérologie de l'Ouest, Centre René Gauducheau, Saint-Herblain, France
- 700 1_
- $a Li, Lingling $u ImmunoGen, Waltham, MA, USA
- 700 1_
- $a Zagadailov, Erin $u ImmunoGen, Waltham, MA, USA
- 700 1_
- $a Diver, Elisabeth J $u ImmunoGen, Waltham, MA, USA
- 700 1_
- $a Trédan, Olivier $u Groupe d'Investigateurs National des Etudes des Cancers Ovariens et du Sein (GINECO), Paris, France; Department of Medical Oncology, Centre Léon Bérard, Lyon, France
- 700 1_
- $a Hilpert, Felix $u Jerusalem Hospital, Hamburg, Germany; Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) study group, Wiesbaden, Germany. Electronic address: hilpert@mammazentrum.eu
- 773 0_
- $w MED00011558 $t Lancet oncology $x 1474-5488 $g Roč. 26, č. 4 (2025), s. 503-515
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/40179908 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250708 $b ABA008
- 991 __
- $a 20250731091613 $b ABA008
- 999 __
- $a ok $b bmc $g 2366809 $s 1253343
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2025 $b 26 $c 4 $d 503-515 $e - $i 1474-5488 $m Lancet oncology $n Lancet Oncol $x MED00011558
- LZP __
- $a Pubmed-20250708
